Malte - anglais - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, tetanus toxoid - suspension for injection - pertactin 3 µg pertussis toxoid 2.5 µg diphtheria toxoid filamentous haemagglutinin (fha) 5 µg fimbriae types 2 and 3 5 µg tetanus toxoid - vaccines

Malte - anglais - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection - pertactin 2.5 µg pertussis toxoid 8 µg diphtheria toxoid filamentous haemagglutinin (fha) 8 µg tetanus toxoid - vaccines

Malte - anglais - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 8 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 25 µg tetanus toxoid - vaccines

Malte - anglais - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 3 µg pertussis toxoid 20 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 20 µg fimbriae types 2 and 3 5 µg haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Australie - anglais - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 8 microgram; tetanus toxoid, quantity: 20 iu; pertactin, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 8 microgram; poliovirus, quantity: 32 agu - injection, suspension - excipient ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin b sulfate; glucose monohydrate; ascorbic acid; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - boostrix-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,boostrix-ipv is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the nhmrc currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,for those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,the nhmrc currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dtpa at 15 to 17 years of age. before the eighth birthday, dtp-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. after the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dtpa or dt-containing vaccines) should be given.,a booster dose of dtpa is also recommended:,? before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? for adults working with young children,? for any adult expressing an interest in receiving a booster dose of dtpa, provided that a primary course of dtp vaccine has been given in the past.,clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given boostrix-ipv (see section 5.1 pharmacodynamic properties).,finally, all adults who reach the age of 50 years without having received a boosting dose of dt in the previous 5 years should receive a further boosting dose of dt, where the adult/adolescent formulation dtpa can be used instead.,boostrix-ipv is not intended for primary immunisation.

Malte - anglais - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis filamentous, haemagglutinin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - powder and suspension for suspension for injection - pertactin 8 µg pertussis filamentous haemagglutinin 25 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu/0.5ml poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu/0.5ml poliovirus (inactivated) type 3 (saukett strain) 32 dagu/0.5ml diphtheria toxoid haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Malte - anglais - Medicines Authority

nm pharma limited 3/4, cantrija complex triq it-targa, il-maghtab naxxar nxr 6613 , malta - diphtheria toxoid, tetanus toxoid, poliomyelitis virus, inactivated type, aluminium hydroxide - suspension for injection - diphtheria toxoid 2 iu tetanus toxoid 2 iu poliomyelitis virus inactivated type 1 40 dagu poliomyelitis virus inactivated type 2 8 dagu poliomyelitis virus inactivated type 3 32 dagu aluminium hydroxide 0.35 mg - vaccines

Irlande - anglais - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified diphtheria toxoid ph. eur.; purified tetanus toxoid; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus; haemophilus influenzae type b, conjugate with tetanus protein - powder for suspension for injection - 0.5 millilitre(s) - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Australie - anglais - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; poliovirus, quantity: 64 dagu; poliovirus, quantity: 80 dagu - injection, suspension - excipient ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin b sulfate; water for injections; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - infanrix hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b. infanrix hexa is also indicated for use as booster dose if boosting with hepatitis b, poliomyelitis, and haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. refer to dosage and administration for further information.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] ((2 lfu)); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; tetanus toxoid 20 [iu] ((5 lfu)) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] ((2 lfu)) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug tetanus toxoid 20 [iu] ((5 lfu)) excipient: aluminium phosphate phenoxyethanol water for injection - adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.